MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202901

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

It was reported that during a shoulder cuff repair surgery, when the package was opened, the head of the 4.5mm footprint ultra pk suture anchor was split and could not be used.The procedure was successfully completed using a back-up device, but it is unknown if there was a surgical delay due to the reported event.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the customer provided image found the anchor attached to the inserter with the stay suture unwrapped from the handle.No split or fracture of the anchor can be seen in the image.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A visual inspection of the returned device found that it is not in its original packaging.The insertion device, anchor and some suture material were returned.The anchor is fractured at the proximal end and there is biological debris in the anchor portion that was retained on the insertion device and on the suture material.A review of the customer provided image found the anchor attached to the inserter with the stay suture unwrapped from the handle.No split or fracture of the anchor can be seen in the image.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15201133
• MDR Text Key: 298292394
• Report Number: 1219602-2022-01131
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 03596010650528
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 2073011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1